Home / Recalls / Edge Pharma, LLC / D-0440-2022

D-0440-2022 Class II Terminated

Recalled by Edge Pharma, LLC — Colchester, VT

Recall Details

Product Type
Drugs
Report Date
February 2, 2022
Initiation Date
December 6, 2021
Termination Date
June 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
221 jars

Product Description

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10

Reason for Recall

CGMP Deviations

Distribution Pattern

nationwide

Code Information

08-2021-16@12 02-01-2022 09/21/21 - 10/19/21 09-2021-13@8 02-01-2022 11/04/21 - 11/17/21 09-2021-29@8 03-01-2022 10/18/21 - 11/11/21 10-2021-26@7 04-24-2022 11/17/21 - 12/01/21

Other recalls by Edge Pharma, LLC

  • D-0412-2022 Class II — MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.1 (December 6, 2021)
  • D-0430-2022 Class II — Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per v (December 6, 2021)
  • D-0403-2022 Class II — Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL (December 6, 2021)
  • D-0448-2022 Class II — Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, (December 6, 2021)
  • D-0419-2022 Class II — Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preserva (December 6, 2021)
  • D-0405-2022 Class II — Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preserva (December 6, 2021)
  • D-0432-2022 Class II — CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortis (December 6, 2021)
  • D-0421-2022 Class II — Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic So (December 6, 2021)
  • D-0429-2022 Class II — Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for (December 6, 2021)
  • D-0423-2022 Class II — Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0 (December 6, 2021)